As reported, after an unknown amount of time from the primary left tsa surgery, this (b)(6) y/o male patient's left humeral liner separated from the humeral tray.The surgeon removed the preserve stem, zero humeral tray, 46 neutral humeral liner and 46 inset glenosphere and was replaced with a 42+4 glenosphere.There was ¿no breakage or surgical delay¿.Patient was last known to be in stable condition following the event.
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Section h10: (h3) the revision reported was likely the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities, which led to humeral liner disassociation.Section h11: *the following sections have corrected information: (d2b) common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented (d4) catalog number: 320-46-00, serial number: (b)(6), expiration date: 26-mar-2022, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 300-30-06, (b)(6) - equinoxe preserve stem 6mm.320-02-46, (b)(6) - 46x21mm glenosphere high moment arm.320-10-00, (b)(6) - equinoxe reverse tray adapter plate tray +0.320-15-05, (b)(6) - eq rev locking screw.320-20-00, (b)(6) - eq reverse torque defining screw kit.
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